Registry evidence

Scleroderma (Systemic Sclerosis) and Haematopoietic stem-cell transplantation (HSCT): what the trial registry contains

The ClinicalTrials.gov registry holds 24 records for HSCT in Scleroderma (Systemic Sclerosis): 3 recruiting now, 4 labelled Phase 3 or 4, across 7 countries. Snapshot 2026-08-29.

Medical review statusMedically reviewedReviewed by: Stem Plus medical teamReviewed on: 2026-08-29Last evidence update: 2026-08-29Methodology and editorial standards
Clinical review team: Dr Kamelia Milcheva, Hematologist · Dr Vadym Uvarov, Board-Certified Physician · Hepatobiliary Surgeon · Candidate of Medical SciencesEditorial responsibility: StemCellAtlas research teamEducational information only. This page does not provide medical advice, diagnosis or a treatment recommendation.

Why this is studied in Scleroderma (Systemic Sclerosis)

Systemic sclerosis combines vascular injury, autoimmunity and progressive fibrosis of skin and internal organs. Autologous haematopoietic transplantation has controlled trial evidence in severe rapidly progressive disease — with real treatment-related mortality — making this an indication where risk-benefit must be stated explicitly rather than implied.

What HSCT means in this table

Haematopoietic transplantation is the oldest and most consequential cell therapy in medicine, with conditioning regimens that carry real mortality risk alongside genuine disease-modifying power. Registrations under this label therefore mix decades-old standard-of-care protocols with newer autoimmune-reset trials, and the risk profile is nothing like that of an outpatient infusion.

The numbers

Every figure below comes from one reproducible query (systemic sclerosis x hematopoietic stem cell transplantation) run against ClinicalTrials.gov API v2 on 2026-08-29.

MetricValue
Registered studies (all statuses)24
Interventional studies in the sample21
Recruiting right now3
Completed10
Terminated, withdrawn or suspended7
Phase 3 or Phase 4 records4
Countries with at least one site7
Median planned enrolment20 participants
Largest single planned enrolment82 participants
First / most recent start year1999 — 2026

How mature is this evidence?

The field has produced some later-stage designs — 4 of the 24 records carry a Phase 3 or 4 label — but the bulk of activity remains earlier-phase safety and signal-finding work.

Completion status: 10 completed, 7 stopped early (29% of all records). A registration is a plan, not a result.

Phase labelRecordsShare
Phase 21346%
Phase 1725%
Phase 3311%
Not applicable311%
Early Phase 114%
Phase 414%

Median planned enrolment is 20 participants (largest single study: 82). Trials of this size can describe safety and generate hypotheses; detecting a modest clinical benefit reliably usually needs substantially larger numbers with a control group.

Where the studies are

Sites are spread across 7 countries, with United States accounting for roughly 69% of country mentions — geography reflects where regulators permit this work and where sponsors sit, not where care is best.

CountryStudies with a site there
United States18
France2
Canada2
Germany1
Italy1
Netherlands1
United Kingdom1

Legal pathway differs by country — see where cell therapy is legal, by country.

Who runs them

Sponsorship leans academic: 6 of the most frequent lead sponsors read as academic or hospital entities and 5 as companies. Who pays shapes what gets measured and what gets published.

  • Fred Hutchinson Cancer Center — 3 records
  • Northwestern University — 3 records
  • European Society for Blood and Marrow Transplantation — 2 records
  • Baylor College of Medicine — 1 record
  • University Hospital Tuebingen — 1 record
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — 1 record

Representative registered studies

Recruiting studies first, then the most advanced phases. Each identifier links to the registry record, where eligibility criteria, outcome measures and contacts are published.

StudyPhaseStatusPlanned nLead sponsorStart
NCT05029336 — Autologous Stem Cell Transplant (ASCT) for Autoimmune DiseasesPhase 2Recruiting20Stephan Grupp MD PhD2026-03
NCT06619561 — A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)Phase 2Recruiting48Deciphera Pharmaceuticals, LLC2024-11-21
NCT03630211 — Autologous Stem Cell Transplantation in Patients With Systemic SclerosisPhase 2Recruiting8Paul Szabolcs2018-07-31
NCT04380831 — TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic SclerosisEarly Phase 1Active Not Recruiting15City of Hope Medical Center2022-02-24
NCT04464434 — Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic SclerosisPhase 4Completed60UMC Utrecht2020-09-17
NCT03593902 — Cardiac Safe Transplants for Systemic SclerosisPhase 2, Phase 3Terminated9Northwestern University2018-05-17
NCT01445821 — Autologous Stem Cell Systemic Sclerosis Immune Suppression TrialPhase 3Terminated44Northwestern University2011-09-15
NCT00114530 — Scleroderma: Cyclophosphamide or TransplantationPhase 2, Phase 3Completed75National Institute of Allergy and Infectious Diseases (NIAID2005-06
NCT07734012 — Mycophenolate After Stem Cell Transplant for Systemic SclerosisPhase 2Not Yet Recruiting6Ottawa Hospital Research Institute2026-08
NCT05098145 — A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic SclerosisPhase 1, Phase 2Withdrawnn/aTalaris Therapeutics Inc.2021-11-24

What this page does and does not tell you

A registry is a plan repository. Counting entries tells you what people intended to study, which is a weaker thing than what they found.

If a clinic offers you this today, the useful question is not "is there research?" but "which of these registered studies is mine part of, and if none, what evidence applies to the exact product I am being sold?" The Provider Question Builder turns that into a scored checklist.

Frequently asked

How many HSCT studies for Scleroderma (Systemic Sclerosis) are recruiting right now?

3 of 24 registered records were listed as recruiting in the 2026-08-29 snapshot. Recruitment status changes frequently; the registry record is authoritative.

Is HSCT an approved treatment for Scleroderma (Systemic Sclerosis)?

Registration on ClinicalTrials.gov is not approval. Approval is granted by a regulator for a specific product and indication after review of submitted evidence. 24 registered studies tell you research exists, not that a product cleared review.

How advanced is the research on HSCT for Scleroderma (Systemic Sclerosis)?

4 of 24 records carry a Phase 3 or Phase 4 label and 10 are marked completed. Registrations run from 1999 to 2026.

Registry and literature counts retrieved 2026-08-29 (ClinicalTrials.gov API v2; PubMed E-utilities). Registration or publication volume measures research activity, not effectiveness or approval. Educational information — not medical advice; verify product, indication, legal pathway and evidence with an independent qualified physician. Page generated 2026-08-29. See our editorial standards.

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Query totals are full API matches; status, phase and country counts describe the first up to 400 returned records per query. Query classes overlap and must not be summed as unique trials. Counts are not treatment outcomes. Snapshot: 2026-08-29. Methods and field definitions.